Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20100204335 A1
Publication typeApplication
Application numberUS 12/627,809
Publication dateAug 12, 2010
Priority dateDec 1, 2008
Also published asCA2745464A1, CN102271654A, CN102271654B, EP2370049A1, WO2010065487A1
Publication number12627809, 627809, US 2010/0204335 A1, US 2010/204335 A1, US 20100204335 A1, US 20100204335A1, US 2010204335 A1, US 2010204335A1, US-A1-20100204335, US-A1-2010204335, US2010/0204335A1, US2010/204335A1, US20100204335 A1, US20100204335A1, US2010204335 A1, US2010204335A1
InventorsFrederick C. Beddingfield, John G. Walt, Christine Somogyi, Chetan Pujara, Julie Albright
Original AssigneeAllergan, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Kit and composition for eyelash growth
US 20100204335 A1
Abstract
The invention provides a kit for enhancing the appearance of eyelashes, comprising an eyelash enhancing composition and delivery system. The eyelash enhancing composition comprises an effective amount of 0.03% bimatoprost. The delivery system comprises a plurality of applicator brushes designed to deliver a fraction of 1-drop bimatoprost dose to the target area.
Images(3)
Previous page
Next page
Claims(21)
1) A kit for enhancing the appearance of eyelashes, comprising: an eyelash enhancing composition and a delivery system, wherein the eyelash enhancing composition comprises an effective amount of 0.03% bimatoprost solution and wherein the delivery system comprises a plurality of applicator brushes having filaments designed to deliver a fraction of a 1-drop bimatoprost dose directly to the target treatment area.
2) The kit of claim 1, wherein the delivery system controls the rate of release of the composition from the brush to an eye surface.
3) The kit of claim 1 wherein the delivery system delivers a bimatoprost dose which is 5% of the bimatoprost dose delivered by 1 drop of bimatoprost for treatment of glaucoma or lowering IOP.
4) The kit of claim 1, wherein the target treatment area is the upper eyelid margin.
5) The kit of claim 1, wherein the applicator brush is sterile.
6) The kit of claim 1, wherein the applicator brush is disposable.
7) The kit of claim 1, wherein the composition is disposed within a dispensing container.
8) The kit of claim 7, wherein the dispensing container is squeezable.
9) The kit of claim 7, wherein a maximum of 3 ml of the composition is disposed in the dispensing container.
10) The kit of claim 1, wherein the applicator brushes are packaged in a plastic sheath.
11) The kit of claim 1, wherein the applicator brushes are packaged in sets of two.
12) The kit of claim 1, wherein the kit contains 60 applicator brushes.
13) The kit of claim 1, further comprising instructions for using the eyelash enhancing composition and delivery system.
14) The kit of claim 13, wherein the delivery system, composition and instructions are enclosed in a box.
15) The kit of claim 14, wherein the container of the composition and the instructions are contained in a first box, and wherein the delivery system is contained in a second box and wherein the first box and second box are contained together in a third box.
16) A method of enhancing the growth of eyelashes wherein the amount of bimatoprost applied a per eyelid margin is 5-12 μg/drop of bimatoprost.
17) The method of claim 16 wherein the amount of bimatoprost applied per eyelid margin per day is 9 μg/drop of bimatoprost.
18) The method of claim 17 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 2-8% of a 30 μL dose of 0.03% bimatoprost.
19) The method of claim 17 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 3-7% of a 30 μL dose of 0.03% bimatoprost.
20) The method of claim 17 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 4-6% of a 30 μL dose of 0.03% bimatoprost.
21) The method of claim 17 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 5% of a 30 μL dose of 0.03% bimatoprost.
Description
    RELATED APPLICATION
  • [0001]
    This application claims the benefit of U.S. Provisional Application Ser. No. 61/118,841, filed Dec. 1, 2008, the disclosure of which is hereby incorporated in its entirety herein by reference.
  • FIELD OF THE INVENTION
  • [0002]
    Bimatoprost solution 0.03% has been shown to be safe and effective for the following proposed indication:
  • [0003]
    Bimatoprost solution 0.03% is indicated to improve the prominence of natural eyelashes as measured by increases in growth (length), fullness (thickness), and darkness (intensity).
  • [0004]
    The proposed dosing regimen is one application nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile single-use-per-eye disposable applicators. The proposed packaging and use is included in FIGS. 1 and 2A-B.
  • BACKGROUND OF THE INVENTION
  • [0005]
    Bimatoprost is a synthetic prostaglandin F analog, developed by Allergan, Inc. and widely used as an ophthalmic preparation (bimatoprost ophthalmic solution 0.03%) for the treatment of ocular hypertension and open-angle glaucoma. Initial approval of bimatoprost ophthalmic solution 0.03% came from the United States Food and Drug Administration (FDA) in March 2001 and it is currently approved in more than 80 countries worldwide, with approximately 9 million patient-years of exposure worldwide. Initially in clinical trials and later in broad scale use, it became apparent that bimatoprost increases the growth of eyelashes. Based on this observation and after amassing a large safety database on bimatoprost, Allergan developed a clinical program in consultation with the FDA to prospectively assess in a controlled manner the safety and efficacy of bimatoprost solution 0.03% for the improvement of eyelash prominence, length, thickness, and darkness in a healthy adult population.
  • [0006]
    Bimatoprost for eyelash growth (bimatoprost solution 0.03%) (referred to in this document as BEG) and bimatoprost for the treatment of glaucoma (bimatoprost ophthalmic solution 0.3% marketed as LUMIGAN®) contain the same active product ingredient, in the same formulation (sterile sodium chloride solution in purified water preserved with benzalkonium chloride), at the same concentration (0.03%). Both are applied topically; directly to the eye(s) for the treatment of glaucoma and directly to the upper eyelid margins using a sterile, single-use-per-eye applicator for eyelash growth. Application to the upper eyelid margin via the applicator for eyelash growth delivers approximately 5% of the volume of the drop administered for the treatment of glaucoma.
  • [0007]
    The safety of bimatoprost is well established, with a large clinical safety database as well as 7 years of postmarketing pharmacovigiliance data. Since the proposed product BEG contains the same active product ingredient, at the same concentration and formulation as bimatoprost for the treatment of glaucoma, and since both are topically applied, the clinical development program for the treatment of glaucoma provides important support for the safety and efficacy of the new drug application (NDA) currently under review.
  • Clinical Development Program
  • [0008]
    Based on the observation of a market need for safe and effective products for enhancing eyelash length, thickness and pigmentation, a clinical development program for an indication of eyelash growth was pursued. The clinical development program was the subject of discussion with the FDA and represents the results of collaboration in the design and execution of studies in this novel area of research.
  • [0009]
    It was first considered to obtain an indication for eyelash growth with bimatoprost topically applied to the eye. However, to better target drug delivery, direct application of the drug to the base of the upper eyelid margin using a singer-use-per-eye applicator was utilized. An open-label, investigator-sponsored clinical study demonstrated both efficacy and optimized safety with direct application of the reduced amount of bimatoprost to the base of the eyelashes. The efficacy of bimatoprost in growing eyelashes was demonstrated in both phase 3 clinical studies of bimatoprost for the treatment of glaucoma.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0010]
    FIG. 1 shows the proposed packaging of bimatoprost solution 0.03% for eyelash growth; and,
  • [0011]
    FIG. 2A-B show the brush and application of bimatoprost solution 0.03% for eyelash growth.
  • SUMMARY OF THE INVENTION
  • [0012]
    The safety of bimatoprost 0.03% has been well characterized. Adverse events reported during the pivotal BEG trial were similar to those reported during the clinical development program for glaucoma and were largely localized to the treatment area. The average amount of bimatoprost solution 0.03% delivered to the upper eyelid margins with the applicator was approximately 5% of that delivered by the indicated dose for the treatment of elevated intraocular pressure (IOP) or glaucoma. As would be expected with the considerably lower drug exposure and application solely to the upper eyelid margins used in BEG compared with instillation of eye drops in the LUMIGAN® trials, the observed adverse events with BEG were milder in severity, had a lower rate of occurrence, and rarely resulted in discontinuation from the study.
  • [0013]
    The adverse events that were most commonly reported by subjects in the bimatoprost-treated group in the pivotal BEG trial were non-serious and predictable based on the known pharmacology of the drug. Consistent with the lower level of exposure compared with treatment of elevated IOP, they were also more likely to be mild in severity. The following adverse events were observed: eye pruritus (5/137, 3.6%), conjunctival hyperemia (5/137 3.6%), skin hyperpigmentation (4/137, 2.9%), pinguecula (3/137, 2.2%), eye irritation (3/137, 2.2%), dry eye (3/137, 2.2%), and erythema of eyelid (3/137, 2.2%). Only 4 of 137 subjects in the bimatoprost group discontinued from the study due an adverse event. Conjunctival hyperemia was the only adverse event reported at a statistically significantly higher rate than vehicle (3.6% versus 0.0%, p=0.028); however, the incidence of conjunctival hyperemia after 4-months of treatment in the pivotal BEG trial was much lower than that observed in trials of LUMIGAN® instilled as a topical ophthalmic for the treatment of elevated IOP (38.4% to 51.8% for QD and BID administration, respectively, after 4 months of treatment in IOP studies).
  • Efficacy Results
  • [0014]
    Bimatoprost solution 0.03% was found to be highly effective. All of the objectives of the pivotal trial were successfully achieved—bimatoprost-treated subjects experienced greater improvements than vehicle-treated subjects in the measurements of eyelash prominence, length, thickness, and darkness, to a highly statistically significant degree (p<0.001 for each endpoint).
  • [0015]
    A statistically significantly higher percentage of subjects in the bimatoprost group compared with the vehicle group experienced improved eyelash prominence (defined as at least a 1-grade increase on the 4-point Global Eyelash Assessment [GEA] scale), length, thickness, and darkness (p<0.0001 for each endpoint). While the primary time point for efficacy was identified a priori as the week 16 visit, statistically significant differences between the bimatoprost group and vehicle group were first observed at week 8 for the primary endpoint of eyelash prominence, at week 4 for the secondary endpoint of eyelash length, and at week 8 for the secondary endpoints of eyelash thickness and darkness. For all endpoints, the difference between the 2 groups became progressively more pronounced with continued treatment and was highly statistically significant at all subsequent time points during the treatment period. The effects of improved eyelash prominence, length, thickness, and darkness continued to be evident to a statistically significant degree in the bimatoprost group as compared to vehicle through the 1-month posttreatment follow-up period.
  • [0016]
    In the evaluation of PROs, subjects in the bimatoprost group as compared with the vehicle group reported a statistically significantly higher degree of satisfaction with their eyelashes in terms of the physical attributes of their eyelashes (i.e., satisfaction with eyelashes in terms of length, fullness, and overall satisfaction), the subjective attributes of their eyelashes (i.e., satisfaction with eyelashes as they relate to feelings of confidence, professionalism, and attractiveness), and the daily routine of making their eyelashes presentable. These results indicate that the eyelash growth experienced by subjects in the bimatoprost group was aesthetically meaningful in terms of their overall satisfaction with their eyelashes.
  • [0017]
    Bimatoprost solution 0.03%, applied topically to the upper eyelid margins at a dose that is approximately 5% of the recommended ophthalmic dose of LUMIGAN®, is safe and effective in improving the prominence of natural eyelashes as measured by increases in growth (length), fullness (thickness), and darkness (intensity). If approved, this product will be the first eyelash enhancement product to be developed under FDA guidance and manufactured under good manufacturing practices, safely satisfying a desired aesthetic need in the marketplace. Given the substantial clinical and postmarketing safety data with bimatoprost ophthalmic solution and the positive results from the pivotal trial for bimatoprost for eyelash growth, it is believed that bimatoprost solution 0.03% can provide patients with meaningful aesthetic benefits with minimal risk. As a prescription drug product with an approved label and risk minimization plan, prescribers and patients would be assured of the safety and efficacy of BEG, which cannot be similarly confirmed for some over the counter or unapproved eyelash treatments.
  • [0018]
    Some embodiments of the invention include:
      • 1) A kit for enhancing the appearance of eyelashes, comprising: an eyelash enhancing composition and a delivery system, wherein the eyelash enhancing composition comprises an effective amount of 0.03% or 0.01% bimatoprost solution and wherein the delivery system comprises a plurality of applicator brushes having filaments designed to deliver a fraction of a 1-drop bimatoprost dose directly to the target treatment area.
      • 2) The kit of paragraph 1, wherein the delivery system controls the rate of release of the composition from the brush to an eye surface.
      • 3) The kit of paragraphs 1 and 2 wherein the delivery system delivers a bimatoprost dose which is 5% of the bimatoprost dose delivered by 1 drop of bimatoprost for treatment of glaucoma or lowering IOP.
      • 4) The kit of any of the paragraphs 1-3, wherein the target treatment area is the upper eyelid margin.
      • 5) The kit of any of the paragraphs 1-4, wherein the applicator brush is sterile.
      • 6) The kit of any of the paragraphs 1-5, wherein the applicator brush is disposable.
      • 7) The kit of any of the paragraphs 1-6, wherein the composition is disposed within a dispensing container.
      • 8) The kit of any of the paragraphs 1-7, wherein the dispensing container is squeezable.
      • 9) The kit of any of the paragraphs 1-8, wherein a maximum of 2 or 3 or 4 or 5 or 6 ml of the composition is disposed in the dispensing container.
      • 10) The kit of any of the paragraphs 1-9, wherein the applicator brushes are packaged in a plastic sheath.
      • 11) The kit of any of the paragraphs 1-10, wherein the applicator brushes are packaged in sets of two or sets of four.
      • 12) The kit of the paragraphs 1-11, wherein the kit contains 60 or 120 applicator brushes.
      • 13) The kit of any of the paragraphs 1-12, further comprising instructions for using the eyelash enhancing composition and delivery system.
      • 14) The kit of any of the paragraphs 1-13, wherein the delivery system, composition and instructions are enclosed in a box.
      • 15) The kit of any of the paragraphs 1-14, wherein the container of the composition and the instructions are contained in a first box, and wherein the delivery system is contained in a second box and wherein the first box and second box are contained together in a third box.
      • 16) A method of enhancing the growth of eyelashes wherein the amount of bimatoprost applied a per eyelid margin is 5-12 μg/drop of bimatoprost.
      • 17) The method of paragraph 16 wherein the amount of bimatoprost applied per eyelid margin per day is 9 μg/drop of bimatoprost.
      • 18) The method of any of the paragraphs 1-17 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 2-8% of a 30 μL dose of 0.03% bimatoprost.
      • 19) The method of any of the paragraphs 1-18 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 3-7% of a 30 μL dose of 0.03% bimatoprost.
      • 20) The method of any of the paragraphs 1-19 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 4-6% of a 30 μL dose of 0.03% bimatoprost.
      • 21) The method of any of the paragraphs 1-20 wherein the amount of 0.03% bimatoprost applied per eyelid margin is 5% of a 30 μL dose of 0.03% bimatoprost.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0040]
    The total dose delivered and therefore the total systemic exposure to bimatoprost with topical application to the upper eyelid margins for the enhancement of eyelash growth are much lower than those for LUMIGAN® ophthalmic solution for the treatment of elevated IOP or glaucoma. In the use of bimatoprost for the treatment of glaucoma, a drop of bimatoprost ophthalmic solution is instilled directly into the eye leading not only to eye exposure but also eyelid skin and eyelash exposure via a bathing of the eyelid margin and eyelashes in the bimatoprost solution.
  • [0041]
    The BEG applicator (see FIGS. 1 and 2) was designed to deliver a fraction of a 1-drop bimatoprost dose directly to the target treatment area. With a single BEG application, approximately 5% of the dose for the treatment of glaucoma is delivered to the upper eyelid margin. The subsequent absorption of bimatoprost from the eyelid surface into the ocular tissues and the body is expected to be incomplete due to the protective skin barrier due to the small surface area upon which the dose is applied.
  • [0042]
    The recommended daily dose of Lumigan is one 30 μL eyedrop applied topically to each eye once daily. The bimatoprost dose contained in each eyedrop is 9 μg, calculated as follows.
  • [0000]

    0.03%=0.03 g/100 mL=30 mg/100 mL=30 μg/100 μL
  • [0000]

    X=30 μL drop*30 μg/100 μL=9 μg/drop
  • [0043]
    With a single BEG application, approximately 5% of this dose is delivered on average to the upper eyelid margin. The subsequent absorption of bimatoprost from the eyelid surface into the ocular tissues and the body is expected to be incomplete due to the protective skin barrier and due to the small surface area upon which the dose is applied (Dugard, 1986; Trommer and Neubert, 2006; Steiling et al, 2001).
  • [0044]
    Other dosing ranges include 0.01-1, 1-9, 2-8%, 3-7%, 4-6% or 5% of a dose of 30 μL LUMIGAN or 0.03% bimatoprost or 1-12, 2-11, 3-10, 4-9, 5-9, 5-9, 6-11, 7-10, 8-10 or 9 μg/drop of bimatoprost or approximately 1.5 μg/drop.
  • [0045]
    Systemic exposure was measured after a 1-drop administration of bimatoprost ophthalmic solution 0.03% to both eyes of 15 healthy subjects once daily for 2 weeks using a state-of-the-art sensitive Liquid Chromatography Coupled with Mass Spectroscopy (LCMS) method during the development of bimatoprost ophthalmic solution 0.03%. The mean Cmax values were similar on days 7 and 14 at approximately 0.08 ng/mL, which was approximately 3 times the lower limit of quantitation of the LCMS method. Because the BEG applicator only transfers a small fraction of the bimatoprost dose onto the eyelid margins (approximately 5%), the systemic exposure of bimatoprost from the BEG application would not have been measurable using this sensitive method.
  • [0046]
    Instructions for use once a day in the evening:
      • 1. Start by ensuring your face is clean, makeup and contact lenses are removed, and any other facial care products have been applied.
      • 2. Remove an applicator from its tray. Then, holding the sterile applicator horizontally, apply one drop of TRADENAME™ to the area of the applicator closest to the tip but not on the tip.
      • 3. Then immediately draw the applicator carefully across the skin of the upper eyelid at the base of the eyelashes (where the eyelashes meet the skin) going from the inner part of your eyelash line to the outer part (see FIG. 2). This area should evenly and lightly moist without runoff.
      • 4. Blot any excess solution beyond the eyelid margin.
      • 5. Dispose of the applicator after one use. Repeat the opposite eyelid margin using a new sterile applicator. This helps minimize any potential for contamination from one eyelid to another.
  • [0052]
    Systemic, ocular, and eyelid exposures to bimatoprost after ophthalmic administration of 1 drop of LUMIGAN® have been demonstrated to be safe through extensive nonclinical and clinical studies and by 7 years of postmarketing surveillance. Specific to eyelid tissues, nonclinical pharmacokinetic research shows that a substantial portion of the ophthalmic bimatoprost dose is absorbed by the eyelid tissues. The total eyelid exposure following BEG application is expected to be less than that following ophthalmic dosing of bimatoprost to the eyes, which is well tolerated. Because of this, the safety of the BEG dose is well supported by extensive safety data from nonclinical, clinical, and postmarketing experience with LUMIGAN®.
  • [0053]
    The safety of bimatoprost for the enhancement of eyelash growth has been demonstrated by the favorable adverse event profile observed in the pivotal BEG trial. In the pivotal BEG trial, bimatoprost solution 0.03% was applied topically to the upper eyelid margins of healthy adult subjects, at a dose approximately 5% of that of a 1-drop dose of LUMIGAN® for the treatment of elevated IOP. As would be expected with the considerably lower exposure from BEG administration as compared with LUMIGAN® administration, adverse events reported during the pivotal BEG trial occurred at a low frequency and were largely mild in severity, aesthetic in nature, and reversible. Adverse events did not usually lead to discontinuation from the study. Importantly, patient satisfaction with bimatoprost treatment was generally not impacted by the experience of an adverse event. As shown in Table I, 72.5% of bimatoprost-treated subjects who experienced any adverse event during the pivotal BEG trial still reported satisfaction with their eyelashes at the end of the treatment period. Interestingly, subjects who did not experience an adverse event reported satisfaction with their eyelashes at a slightly lower rate (60.5%). In terms of the mean change from baseline in scoring of overall satisfaction with eyelashes, bimatoprost-treated subjects who experienced an adverse event reported improved satisfaction of more than 2 points on a 5-point scale (possible answers were very dissatisfied, dissatisfied, neutral, satisfied, and very satisfied), indicating that the experience of an adverse event did not impact the subjects' perception of a benefit from bimatoprost.
  • [0000]
    TABLE I
    Impact of the Experience of an Adverse
    Event on Patient Reported Outcomes
    Bimatoprost Solution 0.03% for Eyelash Growth
    Subjects Reporting Subjects Not Reporting
    Adverse Event(s) Adverse Event(s)
    Subjects feeling 37/51 (72.5)   52 (60.5)
    satisfied or very
    satisfied at Week
    16a, N (%)
    Change from baseline  −2.04 (−1.33) −1.80 (−1.21)
    to week 16
    on overall satis-
    factionb, Mean (SD)
    SD = standard deviation
    aWeek 16 marked the end of the treatment period in the pivotal BEG study (192024-032).
    bThe question, “Overall, how satisfied are you with your eyelashes?” was item #4 on the PRO questionnaire. Subjects answered the question using a 5-point scale; possible answers were very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied. A negative change from baseline indicated an increase in satisfaction.
  • [0054]
    Certain “class effects” commonly associated with prostaglandin F2 analogs, such as skin hyperpigmentation, hair growth outside the treatment area, hyperemia, and iris hyperpigmentation, were reported in the BEG trial by very few subjects. With few exceptions (2 subjects reporting skin hyperpigmentation and 1 subject reporting errant hair growth outside the treatment area), all of these events had resolved prior to the end of the study. IOP reduction, while statistically significantly different between the bimatoprost and vehicle groups, was minimal (i.e., less than 1 mm Hg difference in mean IOP changes from baseline between the 2 treatment groups at any time point during the study) and thus, was not clinically significant.
  • [0055]
    BEG is an aesthetic product. Therefore, its benefits must be considered first from the point of view of the patient. The benefits of bimatoprost solution 0.03% have been clearly demonstrated in the pivotal BEG trial, not only through the clinical measurements of prominence, length, thickness, and darkness, but by the greater increases in satisfaction reported by subjects in the bimatoprost group versus the vehicle group. PRO data indicate that, compared with vehicle-treated subjects, subjects in the bimatoprost group were significantly more satisfied with the physical (e.g., length, fullness) and subjective (e.g., confidence, attractiveness) attributes of their eyelashes, as well as with their eyelashes overall. These results clearly show that the benefits of bimatoprost for eyelash growth are not only noticeable through the statistical interpretation of clinical measurements but are noticeable and appreciated by the persons who use the product. In line with these PRO results, quantitative improvements in eyelashes were demonstrated in the pivotal BEG trial by the significant efficacy of bimatoprost compared with vehicle in the clinical measurements of prominence, length, thickness, and darkness. By the end of the 16-week treatment period, 78.1% of subjects in the bimatoprost group had experienced improved eyelash prominence compared with only 18.4% of subjects in the vehicle group. Subjects in the bimatoprost group had experienced percentage increases in eyelash length, thickness, and darkness of 25%, 106%, and 18%, respectively, while subjects in the vehicle group experienced only 2%, 12%, and 3% increases in eyelash length, thickness, and darkness, respectively.
  • CONCLUSION
  • [0056]
    Bimatoprost solution 0.03%, applied topically to the upper eyelid margins, at approximately 5% the dose used for lowering IOP or treatment of glaucoma, has been conclusively shown to be safe and effective in improving the prominence of natural eyelashes as measured by increases in growth (length), fullness (thickness), and darkness (intensity), thus providing a key benefit desired by consumers. The safety database for bimatoprost is substantial, with clinical trial exposure to bimatoprost estimated at 3461 patient-years and worldwide postmarketing exposure estimated at 9 million patient-years. Bimatoprost ophthalmic solution 0.03% has been used safely and successfully for over 7 years in a large multi-ethnic population around the world. The pivotal trial for bimatoprost for eyelash growth confirmed the highly favorable safety profile that was expected for bimatoprost 0.03% when applied topically to the upper eyelid margins at a dose approximately 5% of the indicated 1-drop LUMIGAN® dose for the treatment of glaucoma. In addition to the favorable safety profile demonstrated in the pivotal BEG trial, excellent efficacy was observed for all endpoints, with differences between bimatoprost and vehicle reaching high statistical significance for the measurements of eyelash prominence, length, thickness, and darkness (p<0.0001 for each endpoint at the primary time point). Patient-reported outcomes results clearly showed that the benefits of bimatoprost for eyelash growth are not only noticeable through the statistical interpretation of clinical measurements, but are noticeable and appreciated by the persons who use the product.
  • [0057]
    Given the long history of clinical and postmarketing safety with bimatoprost ophthalmic solution and the positive results from the pivotal trial for bimatoprost for eyelash growth, it is clear that bimatoprost solution 0.03% can provide meaningful aesthetic benefit to the patients who use it while posing minimal risk. If approved, this product will be the first eyelash enhancement product to be developed under FDA guidance and manufactured under good manufacturing practices. Furthermore, the launch of this product with comprehensive labeling for use under physician supervision and a risk minimization plan including enhanced pharmacovigilance, will further ensure the safe use of the product in the marketplace and allow patient access to a highly desired aesthetic benefit.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3382247 *Nov 1, 1965May 7, 1968Upjohn Co6-amino-1, 2-dihydro-1-hydroxy-2-imino-4-phenoxypyrimidines
US3644363 *Sep 2, 1969Feb 22, 1972Richardson Merrell Inc1 4-dioxidoquinoxalinyl nitrones
US4128577 *Dec 12, 1977Dec 5, 1978The Upjohn Company15-Methyl- and 16-phenoxy-PGF2 α, amides
US4139619 *Aug 19, 1977Feb 13, 1979The Upjohn Company6-Amino-4-(substituted amino)-1,2-dihydro-1-hydroxy-2-iminopyrimidine, topical compositions and process for hair growth
US4311707 *Feb 12, 1979Jan 19, 1982American Cyanamid CompanyProcess for topically producing cutaneous vasodilation for the treatment of vasospastic or ischemic conditions
US4543353 *Oct 25, 1982Sep 24, 1985Farmitalia Carlo Erba S.P.A.Ester and amide derivatives of 13,14-didehydro prostaglandins
US4596812 *Aug 28, 1980Jun 24, 1986The Upjohn CompanyMethods and solutions for treating male pattern alopecia
US4599353 *May 3, 1982Jul 8, 1986The Trustees Of Columbia University In The City Of New YorkUse of eicosanoids and their derivatives for treatment of ocular hypertension and glaucoma
US4812457 *Jan 29, 1988Mar 14, 1989Research Development CorporationProstaglandin derivatives
US4839342 *Sep 3, 1987Jun 13, 1989University Of Georgia Research Foundation, Inc.Method of increasing tear production by topical administration of cyclosporin
US4883581 *Oct 3, 1986Nov 28, 1989Exxon Chemical Patents Inc.Pretreatment for reducing oxidative reactivity of baseoils
US4888354 *Dec 21, 1987Dec 19, 1989Theratech, Inc.Skin penetration enhancement using free base and acid addition salt combinations of active agents
US4889845 *Jan 19, 1988Dec 26, 1989American Cyanamid CompanyVehicle for topical application of pharmaceuticals
US4952581 *Dec 30, 1988Aug 28, 1990The Trustees Of Columbia University In The City Of New YorkUse of a prostaglandin in combination with an adrenergic blocking agent for reduction of intraocular pressure
US4968812 *Jun 23, 1989Nov 6, 1990Shell Oil CompanySpirolactonelactams
US4982838 *May 31, 1989Jan 8, 1991Georg Karl Geka-Brush GmbhDisposable mascara tester
US5001153 *Sep 19, 1988Mar 19, 1991K.K. Ueno Seiyaku Oyo KenkyujoOcular hypotensive agents
US5194429 *Nov 19, 1990Mar 16, 1993K.K. Ueno Seiyaku Oyo KenkyujoOcular hypotensive agents
US5280018 *Jul 10, 1989Jan 18, 1994American Cyanamid CompanyVehicle for optical application of pharmaceuticals
US5288754 *Feb 4, 1992Feb 22, 1994Allergan, Inc.Polar C-1 esters of prostaglandins
US5296504 *Dec 8, 1992Mar 22, 1994Kabi PharmaciaProstaglandin derivatives for the treatment of glaucoma or ocular hypertension
US5321128 *Dec 8, 1992Jun 14, 1994Kabi Pharmacia AbProstaglandin derivatives for the treatment of glaucoma or ocular hypertension
US5352708 *Sep 21, 1992Oct 4, 1994Allergan, Inc.Non-acidic cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents
US5422368 *Dec 8, 1992Jun 6, 1995Kabi Pharmacia AbProstaglandin derivatives for the treatment of glaucoma or ocular hypertension
US5422369 *Feb 25, 1994Jun 6, 1995Kabi Pharmacia AbProstaglanddin derivatives for the treatment of glaucoma or ocular hypertension
US5431881 *Dec 10, 1993Jul 11, 1995Palacios; Henry J.Treatment of hair loss and dermatological problems
US5474979 *May 17, 1994Dec 12, 1995Allergan, Inc.Nonirritating emulsions for sensitive tissue
US5480900 *Apr 10, 1995Jan 2, 1996Alcon Laboratories, Inc.Combinations of prostaglandins and clonidine derivatives for the treatment of glaucoma
US5508303 *May 28, 1993Apr 16, 1996Toray Industries, Inc.Hair-growing composition
US5510383 *Aug 3, 1993Apr 23, 1996Alcon Laboratories, Inc.Use of cloprostenol, fluprostenol and their salts and esters to treat glaucoma and ocular hypertension
US5545655 *Nov 23, 1994Aug 13, 1996Uniroyal Chemical Company, Inc.Substituted oxathiolanes
US5578618 *Feb 16, 1995Nov 26, 1996Pharmacia AktiebolagProstaglandin derivatives for the treatment of glaucoma or ocular hypertension
US5578643 *Aug 4, 1994Nov 26, 1996Loyola University Of ChicagoProtective prostaglandins for use in conjunction with chemotherapeutic agents
US5607978 *Jan 11, 1995Mar 4, 1997AllerganNon-acidic cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents
US5688819 *Feb 22, 1996Nov 18, 1997AllerganCyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents
US5698733 *Jun 7, 1995Dec 16, 1997Alcon Laboratories, Inc.Use of 9-deoxy prostaglandin derivatives to treat glaucoma
US5773472 *Nov 3, 1994Jun 30, 1998Pharmacia AbMethod and means for prevention of cataract
US5789244 *Jan 8, 1996Aug 4, 1998Canji, Inc.Compositions and methods for the treatment of cancer using recombinant viral vector delivery systems
US6025392 *Jul 2, 1998Feb 15, 2000Alcon Laboratories, Inc.substituted tetrahydrofuran analogs of prostaglandins as ocular hypotensives
US6124344 *Nov 19, 1997Sep 26, 2000Allergan Sales, Inc.Cyclopentane heptan(ene)oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents
US6160129 *Feb 1, 1999Dec 12, 2000Allergan Sales, Inc.Cyclopentane heptan(ene)oic acid, 2-heteroarylalkenyl derivatives as therapeutic agents
US6232344 *Dec 4, 1998May 15, 2001Alcon Laboratories, Inc.13-Oxa prostaglandins for the treatment of glaucoma and ocular hypertension
US6254860 *Apr 13, 1999Jul 3, 2001Allergan Sales, Inc.Ocular treatment using cyclosporin-A derivatives
US6258844 *May 14, 1997Jul 10, 2001Allergan Sales, Inc.Cyclopentane (ene) oic acid, 2-alkenyl derivatives as therapeutic agents
US6262105 *Aug 3, 1999Jul 17, 2001Murray A. JohnstoneMethod of enhancing hair growth
US6350442 *May 30, 2001Feb 26, 2002Allergan Sales, Inc.Ocular treatment using cyclosporin-A derivatives
US6403649 *Mar 6, 2000Jun 11, 2002Allergan Sales, Inc.Non-acidic cyclopentane heptanoic acid,2-cycloalkyl or arylalkyl derivatives as therapeutic agents
US6441047 *Mar 12, 1999Aug 27, 2002Alcon Manufacturing Ltd..Combination therapy for treating glaucoma
US7223724 *Feb 7, 2000May 29, 2007Human Genome Sciences, Inc.Use of vascular endothelial growth factor to treat photoreceptor cells
US7351404 *Jan 15, 2003Apr 1, 2008Allergan, Inc.Method of enhancing hair growth
US7368436 *Aug 30, 2001May 6, 2008The University Of British ColumbiaTRPM-2 antisense therapy
US7388029 *May 26, 2005Jun 17, 2008Duke UniversityCompositions and methods for treating hair loss using non-naturally occurring prostaglandins
US7514474 *Sep 23, 2008Apr 7, 2009Meta Cosmetics, LlcProstaglandin analog compositions and methods to treat epithelial-related conditions
US8038988 *Oct 18, 2011Allergan, Inc.Method of enhancing hair growth
US8101161 *May 22, 2007Jan 24, 2012Allergan, Inc.Method of enhancing hair growth
US9009430 *Nov 29, 2011Apr 14, 2015International Business Machines CorporationRestoration of data from a backup storage volume
US9009431 *May 29, 2012Apr 14, 2015Compellent TechnologiesVirtual snapshot system and method
US20020044953 *Jul 30, 2001Apr 18, 2002Michelet Jean FrancoisUse of non-prostanoic agonists of prostaglandin EP-2 and/or EP-4 receptors as cosmetic agents for attenuating, reducing or stopping the loss of head hair and other hairs
US20020103255 *Jan 28, 2002Aug 1, 2002Hellberg Mark R.Use of non-steroidal anti-inflammatory agents in combination with prostaglandin FP receptor agonists to treat glaucoma and ocular hypertension
US20020172693 *Jan 31, 2001Nov 21, 2002Delong Michell AnthonyCompositions and methods for treating hair loss using non-naturally occurring prostaglandins
US20030083381 *Mar 31, 2001May 1, 2003Hiroki KumagaiHair growth or hair formation controlling agents
US20030147823 *Jan 15, 2003Aug 7, 2003Allergan, Inc.Method of enhancing hair growth
US20030199590 *Jul 25, 2002Oct 23, 2003Cagle Gerald DProstaglandin analogues for promotion of hair growth
US20040052760 *Apr 23, 2003Mar 18, 2004Societe L'oreal S.A.Cosmetic composition, method of cosmetic treatment and preparation of a composition for promoting the growth and/or preventing or delaying the loss of hair
US20050222232 *May 26, 2005Oct 6, 2005Duke UniversityCompositions and methods for treating hair loss using non-naturally occurring prostaglandins
US20050252824 *May 17, 2004Nov 17, 2005Brenda ChristianMascara assembly
US20060140708 *Nov 9, 2005Jun 29, 2006Byun Young KLiquid cosmetic case
US20070078175 *Oct 5, 2006Apr 5, 2007L'orealAdministration of novel phenylfurylmethylthiazolidine-2,4-dione and phenylthienylmethylthiazolidine-2,4-dione compounds for stimulating or inducing the growth of keratinous fibers and/or slowing loss thereof
US20070160562 *Jan 5, 2007Jul 12, 2007Brinkenhoff Michael CDelivery devices for hair-promoting cosmetic agent
US20070243230 *Apr 2, 2007Oct 18, 2007Forsight Labs, LlcNasolacrimal Drainage System Implants for Drug Therapy
US20080041749 *Aug 21, 2006Feb 21, 2008Mcdermott Charles DRe-closable vessel system for repeat administration of a drug product and method
US20080070988 *Nov 21, 2007Mar 20, 2008Allergan, Inc.Method of Enhancing Hair Growth
US20080275118 *Jun 12, 2008Nov 6, 2008Shaw Mari MHealth and cosmetic composition and regime for stimulating hair growth and thickening on the head, including the scalp, eyelashes, and eyebrows, and which discourages hair loss
US20090018204 *Jun 4, 2008Jan 15, 2009Brinkenhoff Michael CComposition and method for enhancing hair growth
US20090270392 *Oct 29, 2009Allergan, Inc.Substituted gamma lactams as therapeutic agents
US20110002866 *Sep 14, 2010Jan 6, 2011Lubit Beverly WMethods to prevent a hair-related side effect of treatment with a chemotherapeutic agent
US20110112198 *May 12, 2011Allergan, Inc.Compositions for enhancing hair growth
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US8222047Sep 23, 2008Jul 17, 2012Quanterix CorporationUltra-sensitive detection of molecules on single molecule arrays
US8236574Mar 24, 2010Aug 7, 2012Quanterix CorporationUltra-sensitive detection of molecules or particles using beads or other capture objects
US8415171Mar 24, 2010Apr 9, 2013Quanterix CorporationMethods and systems for extending dynamic range in assays for the detection of molecules or particles
US8783451Feb 16, 2012Jul 22, 2014Allergan, Inc.Unit dose breakable vial with integrated brush applicator
US8846415Jun 19, 2012Sep 30, 2014Quanterix CorporationUltra-sensitive detection of molecules on single molecule arrays
US9110025Mar 1, 2011Aug 18, 2015Quanterix CorporationMethods and systems for extending dynamic range in assays for the detection of molecules or particles
US20100075407 *Sep 23, 2008Mar 25, 2010Quanterix CorporationUltra-sensitive detection of molecules on single molecule arrays
US20110212537 *Mar 24, 2010Sep 1, 2011Quanterix CorporationMethods and systems for extending dynamic range in assays for the detection of molecules or particles
US20110212848 *Mar 24, 2010Sep 1, 2011Quanterix CorporationUltra-sensitive detection of molecules or particles using beads or other capture objects
WO2014168690A1 *Feb 25, 2014Oct 16, 2014Tang Gordon CCosmetic method for changing the appearance of eyes
Classifications
U.S. Classification514/622, 132/218
International ClassificationA61K31/5575, A45D40/26
Cooperative ClassificationA61K8/42, A61K2800/88, A61Q1/10
European ClassificationA61Q1/10, A61K8/42
Legal Events
DateCodeEventDescription
Apr 28, 2010ASAssignment
Owner name: ALLERGAN, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BEDDINGFIELD, FREDERICK C;WALT, JOHN G.;SOMOGYI, CHRISTINE;AND OTHERS;SIGNING DATES FROM 20100106 TO 20100428;REEL/FRAME:024302/0755